Documents
Application Sponsors
NDA 022386 | NOVO NORDISK INC | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | TABLET;ORAL | 500MG;1MG | 1 | PRANDIMET | METFORMIN HYDROCHLORIDE; REPAGLINIDE |
002 | TABLET;ORAL | 500MG;2MG | 1 | PRANDIMET | METFORMIN HYDROCHLORIDE; REPAGLINIDE |
FDA Submissions
TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2008-06-23 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2010-05-28 | UNKNOWN |
LABELING; Labeling | SUPPL | 7 | AP | 2012-03-01 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2012-04-24 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2013-10-17 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2013-10-17 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2014-06-11 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2014-07-29 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2014-06-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2014-06-04 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2017-12-08 | STANDARD |
LABELING; Labeling | SUPPL | 18 | AP | 2017-04-05 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 31 |
SUPPL | 2 | Null | 7 |
SUPPL | 7 | Null | 7 |
SUPPL | 8 | Null | 7 |
SUPPL | 9 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 16 | Null | 15 |
SUPPL | 18 | Null | 15 |
CDER Filings
NOVO NORDISK INC
cder:Array
(
[0] => Array
(
[ApplNo] => 22386
[companyName] => NOVO NORDISK INC
[docInserts] => ["",""]
[products] => [{"drugName":"PRANDIMET","activeIngredients":"METFORMIN HYDROCHLORIDE; REPAGLINIDE","strength":"500MG;1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PRANDIMET","activeIngredients":"METFORMIN HYDROCHLORIDE; REPAGLINIDE","strength":"500MG;2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"12\/08\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022386s016lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022386s018lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2012","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022386s000lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2012","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022386s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/28\/2010","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022386s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022386lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"PRANDIMET","submission":"METFORMIN HYDROCHLORIDE; REPAGLINIDE","actionType":"500MG;1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"PRANDIMET","submission":"METFORMIN HYDROCHLORIDE; REPAGLINIDE","actionType":"500MG;2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-12-08
)
)